Full Time Manufacturing Operations Specialist Jobs, in Coalesce Management Consulting - Maukerja

ROLE OVERVIEW

The Manufacturing Operations Specialist will provide hands-on operational and documentation support for single-use systems within a GMP-regulated biopharmaceutical manufacturing environment. Acting as a shared resource across Single-Use Operations and New Product Introduction teams, the role will support routine manufacturing activities including shop-floor troubleshooting, system readiness, change-control coordination, and GMP documentation.

KEY RESPONSIBILITIES

• Provide day-to-day operational support for single-use systems, assemblies, and consumables used within the manufacturing area.

• Support the set-up, installation, and operational readiness of single-use equipment and process assemblies on the manufacturing floor.

• Respond to time-sensitive issues involving leaks, integrity failures, connection problems, damaged components, and other single-use defects.

• Support investigations by gathering evidence, assessing potential causes, and coordinating follow-up actions with relevant stakeholders.

• Participate in an on-call rotation and provide responsive support within a 24/7 manufacturing environment.

• Initiate and progress change controls for facility expansion, process improvements, equipment changes, and departmental activities from impact assessment through closure.

• Prepare, review, and update SOPs, work instructions, single-use process diagrams, process system diagrams, and supporting technical documentation.

• Support deviations, investigations, CAPAs, and other quality-system records relating to single-use operations.

• Review single-use diagrams and process information to confirm configurations are suitable for their intended manufacturing use.

• Coordinate operational-readiness, documentation, and handover activities across Operations, NPI, Quality, Engineering, Validation, Supply Chain, and vendors.

• Maintain complete, traceable, and inspection-ready records in accordance with GMP, Good Documentation Practices, and data-integrity requirements.

• Identify opportunities to improve the reliability, usability, and standardisation of single-use systems and associated operational processes.

CANDIDATE REQUIREMENTS

• Bachelor's degree in Engineering, Biotechnology, Life Sciences, Pharmaceutical Science, or a related discipline.

• Approximately five years of relevant experience within a GMP-regulated biotechnology, biopharmaceutical, or pharmaceutical manufacturing environment.

• Practical experience supporting site-based manufacturing operations and responding to time-sensitive shop-floor issues.

• Proven experience managing change controls, including initiation, impact assessment, implementation, action coordination, and closure.

• Strong GMP documentation experience covering deviations, investigations, CAPAs, SOPs, and controlled-document revisions.

• Able to interpret process documentation, technical diagrams, and equipment or system information.

• Strong attention to detail, organisation, communication, and cross-functional stakeholder-management skills.

• Willing and able to participate in a 24/7 on-call support rotation.

PREFERRED EXPERIENCE

• Drug-substance manufacturing experience and knowledge of end-to-end biopharmaceutical processes.

• Hands-on exposure to single-use bags, tubing assemblies, connectors, filters, manifolds, transfer assemblies, or related consumables.

• Experience preparing or interpreting single-use process diagrams and process system diagrams.

• Previous involvement in NPI, technology transfer, facility expansion, manufacturing readiness, or single-use defect investigations.